Guide to FDA Requirements and Importance of Medical Device Calibration
Engineers Design Color- Changing Compression Bandage
Improved 3D Printing for Patient-Specific Medical Diagnosis
Data, Data Everywhere: Why the Medical Device Industry Must Embrace the Fourth Industrial Revolution
Implantable Islet Cells Come with Their Own Oxygen Supply
Evaluating Electronics Contract Manufacturers for Medical Devices
Two-Component Molding Can Solve Medical Design Challenges and Reduce Costs
Therapeutic Gel Shows Promise Against Cancerous Tumors
Scientists Develop Elastic Metal Rods to Treat Scoliosis
Key Factors for Choosing Silicone Solutions in Medical Device Lubrication

Please Login at the top
of the page to download.

Medical device manufacturers must establish quality systems to comply with FDA regulations and industry standards like ISO 13485. This whitepaper explains why product centric QMS solutions are critical to simplify compliance.

Traditional quality management system (QMS) solutions were developed to help comply with regulations with a primary focus on automating paper-based processes. However, today’s complex product medical device manufacturers need systems to manage documents, SOPs, training records, and CAPA/quality processes in addition to the complex product record.

A product centric QMS solution provides a single, unified solution that links quality and training information to the entire product record. Read this whitepaper to learn how this approach simplifies compliance to FDA regulations.